Shelley Facente, Thomas Knoble, Omar Menendez, Teri DowlingSan Francisco Department of Public Health, HIV Prevention Section

Kevin DelaneyDivision of HIV/AIDS Prevention, NCHHSTP, Centers for Disease Control and Prevention

HV Diagnostics ConferenceAtlanta, GA

December 2007

Rapid Testing began in San Francisco in May 2003, with a pilot at one community-based organization, Glide Health Services.

At this time, there are 17 publicly-funded agencies offering rapid HIV testing.

Client assumed HIV-negative

Client assumed HIV-positive

=

=

ReactiveOraQuick

ReactiveStat-Pak

Non-reactive Stat-Pak

ReactiveUni-Gold

Non-reactiveUni-Gold

Non-reactiveOraQuick

* All results following a reactive OraQuick are confirmed via EIA and IFA/WB in the SFDPH Microbiology Lab

Identify necessary resources and staff

Develop and pilot standard operating procedures for the study and sites

Develop and conduct training for all staff

Develop a quality assurance program

CDC funded SF and LA for this study• Included staff salaries, supplies, lab costs, and

travel

San Francisco hired two full-time staff:• One to coordinate the intervention sites• One to coordinate a system for linkage to care

Three other SF staff are devoted part-time:• One to coordinate the study as a whole (.25 FTE)• One to coordinate study data (.5 FTE)• One to coordinate HIV surveillance (.1 FTE)

Each of the five intervention sites identified:

A coordinator responsible for HIV counseling and testing at the site

• Some have a separate person responsible for managing the laboratory procedures

A core group of people who would be trained as technicians to run the second and third rapid tests after a reactive OraQuick

Phlebotomist(s) to be on-site at all times testing is offered

A plan for data collection was developed and forms were created or modified to ensure:• study objectives are measured• quality of study procedures are continuously monitored

A comprehensive study protocol was developed and submitted along with an application to the IRB at UCSF and CDC

All sites were required to complete site-specific protocols according to a template provided by the SFDPH

After meeting with CDC, test manufacturers, and test counselors, two trainings were developed:

•Technicians 8 hour training To date, over 25 technicians have been trained

•Counselors 3 hour training To date, over 100 counselors have been trained

All counselors at each

intervention site were required

to attend a 3-hour training

(many were offered) to review and practice new

counseling messages

Observation Observation • Intervention Site Coordinator conducts weekly site visits to:

observe testing processes, observe counseling messages being used, review quality assurance logs (i.e. temp or control logs), and provide technical assistance

until such time that he is confident that sites are entirely self-sufficient and running with high quality

Running Controls

Competency Assessment Testing (CAT)

Model Performance Evaluation Program (MPEP)

Adjusting Data Collection

Observation

Running ControlsRunning Controls• Each certified tester is required to run controls for each

type of test at least once per month, to keep up skills

Competency Assessment Testing (CAT)

Model Performance Evaluation Program (MPEP)

Adjusting Data Collection

Observation

Running Controls

Competency Assessment Testing (CAT)Competency Assessment Testing (CAT)• Every three months, each certified tester is observed and

documented running both a Stat-Pak and Uni-Gold test.

• If any of these testers do not pass competency, they must retest and pass or lose their certification and cannot run the tests

Model Performance Evaluation Program (MPEP)

Adjusting Data Collection

Observation

Running Controls

Competency Assessment Testing (CAT)

Model Performance Evaluation Program Model Performance Evaluation Program (MPEP)(MPEP)• Each site is enrolled in CDC’s MPEP and the site

laboratory manager must correctly run all six MPEP samples for the OraQuick Advance, Stat-Pak, and Uni-Gold tests twice per year

Adjusting Data Collection

Observation

Running Controls

Competency Assessment Testing (CAT)

Model Performance Evaluation Program (MPEP)

Adjusting Data CollectionAdjusting Data Collection• Tracking and linking each type of test run for a client

• Adapting current logs (temp storage, control) to capture new tests

• Modifying current databases to collect and analyze additional tests and results, including linkage information

Staff and resources must be adequate

A data collection plan must be developed and refined before implementation

A slow roll-out is essential

Our two full-time staff make this possible

Each site having its own coordinator, in constant communication, is also vital

Time to train all counselors and technicians should not be minimized

When you have 5 sites and over 125 counselors and technicians, being clear and consistent is key

Determine up front what data points are needed to ensure quality monitoring and meet study objectives

You can be flexible if things are not working, but adding or changing requirements all the time leads to frustration and failure

Plan carefully, train well, and begin slowly

It takes months to develop a program that works for everybody and uses good lab practices – be prepared

Plan for a smaller pilot program and then scale upward

Communication is key• The CDC, the SFDPH, the city public health lab, and

all site coordinators have been in constant communication throughout planning and implementation

• Accurate results, safety, and sensitive counseling with strong linkages to needed medical care and support services are shared goals for all

San Francisco Department of Public Health

AIDS Office, HIV Prevention SectionSan Francisco, CA

Shelley Shelley FacenteFacenteStudy Data Coordinator

415-554-9136Shelley.Facente@sfdph.o

rg

Omar Omar MenendezMenendez

Coordinator for Linkages415-5703-7280

Omar.Menendez@sfdph.org

Teri DowlingTeri DowlingPrincipal Investigator

415-554-9167Teri.Dowling@sfdph.org

Thomas KnobleThomas KnobleIntervention Site

Coordinator415-703-7279

Thomas.Knoble@sfdph.org

Kevin DelaneyKevin DelaneyCDC Project Officer

404-639-6142khd8@cdc.gov

Centers for Disease Control and Prevention

Division of HIV/AIDS Prevention, NCHHSTPAtlanta, GA